Amines, C16-18 (even numbered)-alkyl , salts with phosphoric acid, mono- and di-C16-18 (even numbered) alkyl esters

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

09 Jan - 26 Mar 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

- strain TA102 or E.coli WP2 was not tested

Principles of method if other than guideline:

Study was performed before actual guideline was adopted (21 Jul 1997).

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

(Z)-octadec-9-enylamine

EC Number:

204-015-5

EC Name:

(Z)-octadec-9-enylamine

Cas Number:

112-90-3

Molecular formula:

CH3(CH2)7CH=CH(CH2)7CH2NH2

IUPAC Name:

octadec-9-en-1-amine

Constituent 2

Reference substance name:

(Z)-octadec-9-en-1-amine

IUPAC Name:

(Z)-octadec-9-en-1-amine

Constituent 3

Reference substance name:

Oleyl Alkylamines

IUPAC Name:

Oleyl Alkylamines

Details on test material:

- Name of test material (as cited in study report): ODA-FG-11-27-84 (Oleylamine)

Method

Target gene:

his operon

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA98, TA100, TA1535, TA1537, TA1538

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 homogenate: from male Sprague-Dawley rats that had been injected with Aroclor 1254 at 500 mg/kg (Aroclor was diluted in corn oil 200 mg/mL); 5 days after injection, the livers were excised and prepared

Test concentrations with justification for top dose:

test 1:
with metabolic activation: 2, 10, 50, 100, 200 µg/plate
without metabolic activation: 0.2, 1, 5, 10, 20 µg/plate

test 2:
with metabolic activation: 2, 10, 25, 50, 100 µg/plate
without metabolic activation: 0.2, 1, 5, 10, 15 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: acetone

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: with metabolic activation: 2-aminoanthracene; without metabolic activation: 2-nitrofluorene, sodium azide, 9-aminoacridine

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Incubation period: 48 hours
- Exposure duration:
- Expression time (cells in growth medium):
- Selection time (if incubation with a selection agent):
- Fixation time (start of exposure up to fixation or harvest of cells):

SELECTION AGENT (mutation assays):
SPINDLE INHIBITOR (cytogenetic assays):
STAIN (for cytogenetic assays):

NUMBER OF REPLICATIONS: triplicate

NUMBER OF CELLS EVALUATED:

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other:

OTHER EXAMINATIONS:
- Determination of polyploidy:
- Determination of endoreplication:
- Other:

Evaluation criteria:

For a test article to be considered positive, it must cause at least a doubling in the mean revertants per plate of at least one tester strain. This increase in the mean number of revertants per plate must be accompanied by a dose response to increasing concentrations of the test article.

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA98, TA100, TA1535, TA1537, TA1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

with metabolic activation: 200 µg/plate; without metabolic activation: 20 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

The results of a preliminary toxicity study of the test article conducted in the presence and absence of S9 mix indicated that the appropriate maximum dose level to be tested in the mutagenicity assay would be 200 µg/plate (with metabolic activation) and 20 µg/plate (without metabolic activation). However, in the mutagenicity experiments, cytotoxicity was observed at lower concentrations (test 1). Therefore, the experiment was repeated in a less toxic dose range (test 2).

Applicant's summary and conclusion

Conclusions:

The test item proved to be negative in this Ames-test

Executive summary:

Octadecenylamine was not mutagenic in bacterial tester strains Salmonella typhimurium TA 98, TA 100, Ta1535, TA1537 and TA1538 in doses up to 20 µg/plate without metabolic activation and up to 200 µg/plate with metabolic activation (Arochlor induced rat liver S-9 mix).